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Osiris Therapeutics, Inc. (OSIR) Release: Grafix® Demonstrates Overwhelming Efficacy in Landmark Stem Cell Study for the Treatment of Diabetic Foot Ulcers


8/13/2013 10:13:27 AM

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COLUMBIA, Md.--(BUSINESS WIRE)--Osiris Therapeutics, Inc. (NASDAQ: OSIR), reported today that its multi-center, randomized, controlled clinical trial comparing the safety and effectiveness of Grafix® to standard of care in patients with chronic diabetic foot ulcers had met the pre-specified stopping rules for overwhelming efficacy as determined by the data monitoring committee during a planned interim analysis. For the primary endpoint, 62% of patients receiving Grafix had complete wound closure compared to only 21% (p<0.0001) of patients who received conventional treatment for their wounds - a relative improvement of 191% and the largest ever reported from such a study. A total of 131 patients were enrolled with the interim analysis being conducted on the first 97 to complete the trial.

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